- On September 23, 2020, the Food and Drug Administration (FDA) published a proposed rule under the Food Safety Modernization Act (FSMA) that would establish “Requirements for Additional Traceability Records for Certain Foods.” As discussed here, FDA concurrently published a new “Food Traceability List” (FTL) designating the high risk foods that will subject persons who manufacture, process, pack, or hold such foods to the proposed additional traceability requirements. FDA is required under FSMA to conduct not less than 3 public meetings in diverse geographical areas of the U.S. to provide persons in different regions an opportunity to comment on the new proposed traceability rule during the formal comment period, which closes January 21, 2020.
- In the October 5, 2020 Federal Register, FDA published details for the 3 required public meetings on the proposed new traceability rule. These meetings will be held virtually to protect the public during the ongoing COVID-19 pandemic. All 3 public meetings will cover the same agenda items. To accommodate persons in different time zones, the 3 meetings will occur with different time frames as follows:
- November 6, 2020 at 8:30 am to 3:30 pm EST,
- November 18, 2020 at 9:30 am to 4:30 pm EST, and
- December 2, 2020 at 11:30 am to 6:30 pm EST.
- At each meeting, FDA will present information on the various sections of the proposed rule. Stakeholder panels will then provide discussion on the various issues. There will also be an opportunity for questions, as well as an opportunity for open public comment.
- Attendance may be limited to those who have registered in advance by October 28, 2020, November 6, 2020, and November 18, 2020 for the first, second, and third meetings, respectively. A limited number of interested parties will be permitted to provide oral presentations upon request, which must be made in advance by October 9, 2020, October 16, 2020, and October 26, 2020 for the first, second, and third meetings, respectively. Keller and Heckman will continue to monitor and report on any updates to the rule and is available to assist in drafting comments. Meeting attendance is not required for submitting comments.